Kornimate/medical-research-clean huggingface dataset:
substudy of meet-os (nct04948632): monitoring of patients after ambulatory surgery by biobeat® devices

Conditions: Surgery-Complications; Patient Satisfaction; Patient Compliance

Summary: the objective of this ancillary study of the meet-os study is to assess the technical feasibility of using biobeat® monitoring devices after ambulatory surgery at high risk of complications. the secondary objectives are to assess: i) the patient's experience and tolerance ii) the occurrence of clinical disturbances in the patients's home after ambulatory surgery with high risk of postoperative complications iii) to determine the impact of the data obtained with the monitoring devices on the clinical care decisions during postoperative follow-up.

with increasingly complex surgeries and increasingly comorbid patients, ambulatory surgery are not always at low risk of postoperative complications. among the new support tools available for monitoring patients remotely, devices for monitoring vital signs could be of interest to healthcare staff in charge of monitoring, more precisely when comorbid patients are involved or when interventions at high risk of complications are performed.

Eligibility criteria:
inclusion criteria: * patients over 18 years old undergoing elective outpatient surgery under general or regional anesthesia * internet access for the patient or their caregiver from home * written, oral and spoken comprehension of french * considered to be at high risk of postoperative complications, defined by one of the following two criteria: an asa 3 score or an asa score of 2 + surgery at intermediate or high risk according to the classification of glance and al. exclusion criteria: * patient's or caregiver's inability to learn and to use digital technologies * conversion of ambulatory to inpatient hospitalization on the day of surgery * patient's refusal * operation performed under regional or neuraxial anesthesia alone * trophic skin disorders contraindicating the installation of the biobeat® monitoring device on the torso (deformation, irritation, infection, ulceration, etc.) * patient with pacemaker * mri or ct scheduled post-operatively * tattoo on the torso or refusal to shave the area where the biobeat® monitoring device should be installed * pregnant or breastfeeding women * allergy to one of the technological components

Keywords: monitoring device ambulatory surgery postoperative complications
mirror therapy: effects on functional recuperation of severe upper limb paresis after stroke

Conditions: Stroke

Summary: after stroke, patients frequently suffer from arm or hand weakness. there are numerous rehabilitation methods to stimulate recovery, amongst which mirror therapy (mt). it is particularly interesting in cases for which impairment is severe, as many other forms of therapy are often impossible. during mt, a mirror is placed in the midsagittal plane, so as to hide the impaired limb. thereafter, the subject is asked to move his unimpaired limb while looking at its reflection in the mirror, thereby creating the illusion that the contralateral, impaired limb is moving. the objective of this study is to better determine the efficacy of mt. the investigators will therefore compare recovery of arm function in two groups of patient, that perform a regimen of 30 minutes of therapy, 5 times a week, for 4 weeks on top of conventional therapy. one group performs mt and the other one performs a therapy in which the same movements are performed, but without the use of a mirror, with unrestricted view of both limbs. allocation to each group will be randomized. arm function will be evaluated by use of a scale before, during and after the 4 week period. the assessor for the primary outcome measure will not know in which group the patient is. there will be a total of 30 patients included over a one year study period.


Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke, diagnosed clinically and by imagery, more than one month after onset; * severe upper limb paresis with upper-extremity fugl-meyer score \< 19/60 . exclusion criteria: * significant limitation in upper limb function predating the recent stroke, caused by former symptomatic stroke and/or an orthopedic/rheumatologic disease; * neuropsychologic or psychiatric impairment with significant interference with participation in therapy; * severe visual impairment.

Keywords: stroke mirror therapy neurorehabilitation
antibiotic-resistant bacterial infection of hepatic patients

Conditions: Antibiotic Resistant Infection; Liver Cirrhoses

Summary: the investigators want to identify the microbial profile, antibiotic resistant bacteria in hepatic patients with infections in liver icu, and explore risk factors and outcomes in those patients with antibiotic resistant bacteria.

bacterial infection signifies major clinical challenge in cirrhotic patients where about 35% of these patients acquire hospital-acquired infections compared with 5% of other hospital in-patients without cirrhosis.it is associated with a mortality rate of 38% with a four-fold increase compared to individuals without cirrhosis. cirrhotic patients have a high risk for antimicrobial resistance because of chronic use of prescribed antibiotics like quinolones in secondary prophylaxis for spontaneous bacterial peritonitis. in addition, undergoing invasive procedures and recurrent hospital admissions encourage both increased occurrence of antimicrobial resistance and the spread of resistant pathogens in these patients. epidemiology, risk factors and clinical outcomes of mdr infections have raised a special attention in cirrhosis. some studies reported bacterial resistance in about 50% of examined patients and it is associated with treatment failure, septic shock and hospital mortality especially in nosocomial and healthcare related infections

Eligibility criteria:
inclusion criteria: * patients with esld at liver icu. all patients have the diagnostic criteria for liver cirrhosis by clinical, biochemical, and ultrasonography findings. the severity of liver cirrhosis will be assessed according to the child-pugh classification and model for end-stage liver disease (meld) score. * these patients are diagnosed as having infection at admission or acquire infection during hospitalization. exclusion criteria: * age ≤ 18 years
clinical value of etcoc in the diagnosis and treatment of abo-hdn

Conditions: ABO Hemolytic Disease of Newborn

Summary: a prospective observational cohort study was designed. 1. comparing of the clinical indicators between the hemolytic group and the non-hemolytic group,such as end-tidal carbon monoxide corrected for ambient co(etcoc),direct antiglobulin test(dat), the highest total serum bilirubin level and hemoglobin. to explore the role of etcoc in the diagnosis of neonatal abo hemolytic disease. 2. comparing of the clinical indicators between the neonates with ivig treatment and the neonates without ivig treatment in abo hemolytic disease, such as etcoc,total serum bilirubin level before ivig treatment and etcoc,total serum bilirubin level after ivig treatment.to explore the clinical value of etcoc in the treatment of abo hemolytic disease.

a prospective observational cohort study was designed. the participants included in the study are the neonates with hyperbilirubinemia in abo incompatibility.because the serological results are not known at the time of enrollment, all the neonates should be suspected hemolysis. according to the serological results,the neonates are divided into two groups, hemolytic group and non-hemolytic group. all the relevant clinical indicators need to be recorded and each neonates needs follow-up.

Eligibility criteria:
inclusion criteria: * gestational age between 35+0 and 41+6 weeks * birth weight ≥ 2500 grams * respiratory rate \< 60 breaths per minute * the neonates admitted to the neonatology department for phototherapy because of hyperbilirubinemia that conforms to the guideline of the experts consensus on the management of neonatal hyperbilirubinemia(2014,in china.) * abo group incompatibility between the mother and newborn * the informed consent are obtained. exclusion criteria: * persistent dyspnea or need for respiratory support * skin damage or structural deformity around the nasal cavity * receive intensive care treatment in the neonatal intensive care unit(nicu) * severe congenital malformation, chromosomal or genetic abnormality

Keywords: end tidal carbon monoxide hyperbilirubinemia abo hemolytic disease of newborn
safety and efficacy of ric in pediatric moyamoya disease patients treated with revascularization therapy

Conditions: Moyamoya Disease; Pediatric

Summary: revascularization surgery has been the standard treatment to prevent ischemic stroke in pediatric moyamoya disease (mmd) patients with ischemic symptoms. however, perioperative complications, such as hyperperfusion syndrome, new infarct on imaging, or ischemic stroke, are inevitable. remote ischemic conditioning (ric) is a noninvasive and easy-to-use neuroprotective strategy, and it has potential effects on preventing hyperperfusion syndrome and ischemic infarction.

this study will provide insights into the preliminary proof of principle, safety, and efficacy of ric in pediatric mmd patients undergoing revascularization surgery therapy, and this data will provide parameters for future larger scale clinical trials if efficacious.

Eligibility criteria:
inclusion criteria: * age: ≥0 and ≤18 * all of the patients underwent digital subtraction angiography and met the current diagnostic criteria recommended by the research committee on mmd (spontaneous occlusion of the circle of willis) of the ministry of health and welfare of japan in 2012 * suzuki stages concentrated in stage iii and iv * presentation with ischemic symptoms, such as transient ischemic attack (tia), headache, seizure, hemorrhagic stroke, and ischemic stroke confirmed by mri * informed consent obtained from patient or acceptable patient's surrogate exclusion criteria: * severe hepatic or renal dysfunction * severe hemostatic disorder or severe coagulation dysfunction * patients with unilateral mmd or the presence of secondary moyamoya phenomenon caused by autoimmune disease, down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy * any of the following cardiac disease - rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with participation * serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year * patient participating in a study involving other drug or device trial study * patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations * unlikely to be available for follow-up for 3 months * contraindication for ric - severe soft-tissue injury, fracture, or peripheral vascular disease in the upper limbs.

Keywords: pediatric moyamoya disease remote ischemic conditioning revascularization therapy
respiratory motion-corrected cone-beam ct and intratreatment gating based on electromagnetic transponders to reduce target position uncertainty in radiation treatment of lung malignancies

Conditions: Lung Cancer

Summary: the first purpose of this study is to test a new computer program that reduces the blurring in the cone-beam ct scan and helps the doctor to better locate the tumor. the investigators want to find out what effects, good and/or bad, that this has on the patient and the way we treat the cancer in the lungs. the second purpose of this study is to test how well this computer program tracks markers in the images, compared to using radio signals to follow the markers.


Eligibility criteria:
inclusion criteria: * histologic proof of malignancy suitable for thoracic radiation therapy * patient is planning to undergo radiation therapy for primary or recurrent malignancies of the lung or metastatic malignancies to the lung. * age ≥ 18 years old * karnofsky performance status ≥ 60% * at least part of the tumor must be visible as observed in a diagnostic or planning ct. * able to have bronchoscopic placement of calypso transponders as confirmed on a recent (within the past 8 weeks) ct scan. exclusion criteria: * patients with clinically significant active infections. * bronchiectasis in the region of the intended implantation. * history of hypersensitivity to nickel. * other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study. * deemed unable to safely undergo or tolerate flexible bronchoscopy as per institutional guidelines * unable to tolerate anesthesia or sedation * enrolled in any other clinical studies the investigator believes to be in conflict with this investigation. * female patients who are pregnant or nursing exclusion criteria for calypso transponders: * implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which calypso medical considers will interfere with the calypso system's electromagnetic localization. * active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effects of the calypso system operation on these devices are unknown. * patients whose lung tumors are being monitored by mr imaging as part of standard clinical care. implantation of transponders will degrade mr images. * posterior lesions that would be \>19 cm distance from calypso detector plate.

Keywords: respiratory motion-corrected cone-beam ct radiation 14-225
endometrial scratching prior to controlled ovarian stimulation (coh) in women undergoing in-vitro fertilization with previous ivf failure

Conditions: Infertility

Summary: scratching the linning of the womb before ivf cycle could increase the chances of having a baby after an ivf cycle.

all women with history of rif (as defined by eshre) and who wish to undertake another assisted conception treatment cycle are invited to participate in the trial. women will be randomised to two arms; one undergoing endometrial sampling and control. women in the experimental arm will be subjected to endometrial scrapping with pipelle biopsy catheter two times; on days 21 and 26 of the cycle prior to the ivf index cycle and after initiation of the gnrha in the long agonist protocol. women in the control group will undergo a placebo procedure using the uterine sound on the same days of the cycle like women in the intervention group.

Eligibility criteria:
inclusion criteria: women with previous ivf failure undergoing ivf treatment - exclusion criteria: * women\>40 years old women undergoing their first ivf treatment cycle
phase i study of ex vivo liver-directed gene therapy for familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia

Summary: objectives: i. develop an approach for treating patients with homozygous familial hypercholesterolemia using gene therapy with autologous hepatocytes transduced with a normal low-density lipoprotein receptor gene.

protocol outline: autologous hepatocytes are obtained from a partial hepatectomy and transduced with a recombinant retroviral vector containing the low-density lipoprotein receptor gene. the transduced hepatocytes are infused via the inferior mesenteric vein 3 days following surgery. traditional therapy is discontinued for 4 weeks prior to protocol therapy and may resume 6 weeks after the hepatocyte infusion.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- homozygous familial hypercholesterolemia, i.e.: low-density lipoprotein (ldl) cholesterol greater than 500 mg/dl autosomal dominant inheritance early-onset tendon and tuberous xanthomas ldl receptor negative, i.e.: receptor binding in cultured fibroblasts no more than 20% of normal or genotype with 2 previously described, disease-causing alleles advanced coronary heart disease with relatively poor prognosis, i.e: angina pectoris history of myocardial infarction positive exercise tolerance test atherosclerotic disease in proximal aorta or coronary arteries by ultrasound or angiogram none of the following: unstable angina pectoris left ventricular ejection fraction less than 30% decompensated congestive heart failure untreated ventricular tachycardia moderate to severe aortic stenosis other dyslipidemia obstructive hepatobiliary disease * prior/concurrent therapy at least 2 weeks since the following: drugs affecting cholesterol metabolism plasma exchange ldl apheresis --patient characteristics-- age: any age renal: no azotemia no significant proteinuria other: no hypothyroidism no diabetes

Keywords: familial hypercholesterolemia inborn errors of metabolism rare disease
a study of cnty-101 in participants with cd19-positive b-cell malignancies

Conditions: R/R CD19-Positive B-Cell Malignancies; Indolent Non-Hodgkin Lymphoma; Aggressive Non-Hodgkin Lymphoma

Summary: elipse-1 is a phase 1, multi-center, dose-finding study to evaluate the safety, pharmacokinetics, and preliminary efficacy of cnty-101 in participants with relapsed or refractory cluster of differentiation (cd)19-positive b-cell malignancies.


Eligibility criteria:
inclusion criteria: 1. diagnosis of cd19-positive relapsed or refractory (r/r) b-cell non-hodgkin's lymphoma (nhl). 2. must have met the following criteria for prior treatment: 1. participants with aggressive nhl must have received at least 2 lines of systemic therapy (if not intended for transplant, have already undergone or be unwilling or unable to undergo chimeric antigen receptor \[car\] t-cell therapy to be eligible), or at least 3 lines of systemic therapy. previous therapy must have included a cd20-targeted agent and an anthracycline or alkylator. 2. participants with follicular lymphoma (fl) must have received at least 2 lines of systemic therapy and have high-risk disease. previous therapy must have included a cd20-targeted agent and an alkylator. 3. participants with marginal zone lymphoma (mzl) must have received at least 2 prior systemic therapies. 3. measurable disease on screening evaluations. 4. eastern cooperative oncology group (ecog) performance status of 0 or 1. 5. adequate organ function. 6. life expectancy of ≥12 weeks. exclusion criteria: 1. any condition that confounds the ability to interpret data from the study. 2. central nervous system (cns)-only involvement by malignancy. (note: participants with secondary cns involvement are allowed.) 3. prior allogeneic stem cell transplant. 4. presence of clinically significant cns pathology. 5. other comorbid conditions defined in the protocol. 6. use of prohibited medications within the washout period defined in the protocol.

Keywords: lymphoma, non-hodgkin lymphoma, large b-cell, diffuse lymphoma, follicular lymphoma, b-cell, marginal zone cellular therapy cell therapy cnty-101 century therapeutics induced pluripotent stem cells car-nk nk cell
trivascular post-market registry

Conditions: Abdominal Aortic Aneurysm

Summary: this is a prospective observational post-market study of subjects receiving the ovation™ or ovation prime™ abdominal stent graft system ("ovation™ or ovation prime™ abdominal stent graft system post-market study") in the treatment of abdominal aortic aneurysms (aaa). the ovation™ or ovation prime™ abdominal stent graft system post-market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the ovation™ or ovation prime™ abdominal stent graft system in actual clinical practice following commercial approval.


Eligibility criteria:
inclusion criteria: * subject is \> 18 years or minimum age as required by local regulations. * indication for elective repair of aaa with an endovascular stent graft in accordance with the instructions for use of the ovation™ or ovation prime™ abdominal stent graft system. * subject has signed an ethics committee (ec) approved informed consent form. the subject or legal representative has been informed of the nature of the study, has consented to participate, and has authorized the collection and release of his/her medical information. * subject intends to electively receive the ovation™ or ovation prime™ abdominal stent graft system. * subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan. exclusion criteria: * subject demonstrates high probability of non-adherence to physician's follow-up requirements. * subject's current participation in a concurrent randomized control trial (rct) or investigational device/drug study which could confound study results. * life expectancy less than 1 year * pregnancy * subjects with poor renal function as indicated by a serum creatinine \> 2.5mg/dl.

Keywords: abdominal aortic aneurysm
evaluating a telemedicine-based intensive treatment program for children and adolescents with obesity

Conditions: Obesity, Childhood

Summary: the study objective is to evaluate whether a novel telemedicine-based intensive treatment program for children with obesity is superior to standard on-site care. this will be a randomized, non-blinded (due to the nature of the intervention) study, where 100 children and adolescents aged 10-18 years with obesity will be divided in a 1:1 ratio to either telemedicine or on-site treatments for 6 months. the telemedicine arm will include 30, mostly video, consultations for each participant: 3 physician appointments, 7 exercise consultations by our exercise physiologist, 10 dietary consultations by our pediatric dietitian, and 10 psychologist consultations to assist with goal setting and overall well-being. three visits will be conducted in-office, for physician assessment, smartphone technical assistance and physical measurements (baseline, at 3 months and at the end of the 6-month period). participants randomized to the telemedicine arm will have a step-counting rewarding app installed on their smartphone by our staff. the in-office arm will have 6 monthly visits during the study period, with two consultations performed in each visit - one by the physician or exercise physiologist, and one by our pediatric dietitian. the main outcome of the study is bmi standard deviation (z-score) changes, which will be evaluated after 3 and 6 months of treatment during physical office visits in both study arms. secondary outcomes will be: * body-fat percent changes, assessed by bioimpedance analysis in physical clinic visits. * daily step counts, measured by smartphone data/ wearable activity tracker, if available. * weight-related quality of life * retention and visit cancellation rates. * satisfaction of both parent and child from their allocated treatment.


Eligibility criteria:
inclusion criteria: * obesity, defined as a bmi at or above 2 standard deviations sds according to the who growth reference * owning a smartphone, needed for video conversations, step counting and the gamification app * parent consent and child's assent to participate in the program exclusion criteria: * significant physical or mental barriers to physical activity and/or to dietary changes (such as autistic spectrum disorder that precludes dietary changes or sufficient exercise, as assessed by the pi)